Staccato Loxapine Thorough QT/QTc
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 10/14/2017 |
| Start Date: | April 2009 |
| End Date: | June 2009 |
Thorough QT/QTc Study of Staccato® Loxapine for Inhalation in Healthy Volunteers
The purpose of the present Phase 1 study is to assess the cardiac safety of Staccato Loxapine
administered to healthy volunteers in a 3 period crossover study.
administered to healthy volunteers in a 3 period crossover study.
Inclusion Criteria:
- Subjects who are in good general health and agree to use a medically acceptable and
effective birth control method throughout the study.
Exclusion Criteria:
- Subjects who have taken prescription or nonprescription medication within 5 days of
treatment,
- Subjects who have had an acute illness within the last 5 days of treatment,
- Subjects who are smokers, OR
- Subjects who have an ECG abnormality at baseline.
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